Clean Utilities Sr Engineer

About the role

In this vital role, you will join the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team. You will design, build, commission, and qualify new equipment and systems needed for drug substance production, and develop subject matter expertise to support operations upon start-up. The Utilities System Owner reports to the Director of the Amgen North Carolina Facilities & Engineering group.

Responsibilities

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, start-up, commissioning, and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practices, rules, and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Provide troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

Requirements

• High school diploma / GED and 10 years of Engineering/Maintenance experience OR
• Associate degree and 8 years of Engineering/Maintenance experience OR
• Bachelor’s degree and 4 years of Engineering/Maintenance experience OR
• Master’s degree and 2 years of Engineering/Maintenance experience OR
• Doctorate degree

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering
• 4+ years of relevant work experience with 2+ years of experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution; and other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
• Experience with equipment and facility control systems operation, logic, and troubleshooting.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g., cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, start-up, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.